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A Phase I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients With Histologically Confirmed Recurrent Malignant Gliomas

Trial Information

A Phase I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients With Histologically Confirmed Recurrent Malignant Gliomas

Oncolytic viruses, such as reovirus, are those viruses which specifically destroy cancer
cells. Reovirus is a common virus that does not cause disease, and has been shown to be
associated with only minor flu-like symptoms. REOLYSIN® is a formulation of the live,
replication-competent wild-type reovirus that selectively replicates in tumor cells, while
leaving healthy cells unharmed.

This phase I/II multi-center study follows a standard design utilizing therapeutic viral
dosage escalation. The phase I portion of the trial will evaluate the doses of
intralesional REOLYSIN titrated to a maximum tolerated dose (MTD). The objective of the
phase II portion of the study is to assess tumor response. The proportion of patients
surviving to six months and the safety of REOLYSIN® are secondary objectives.

Each patient enrolled in the study will receive a single infusion of REOLYSIN® over 72
hours. Patients will remain in hospital for at least 90 hours after initiation of infusion.
Following REOLYSIN® administration, each patient will be followed for at least 12 weeks
(Phase I) and at least 6 months (Phase II) with regular evaluation visits (weekly and then
monthly). Evaluations will include tumor measurements, serial neurologic exams and
functional performance status assessments at baseline, prior to hospital discharge, and at
weeks 4, 8, 12, 16 and 24 after REOLYSIN® therapy. Changes in performance will be assessed
using the Karnofsky Performance Status scale. Subjects will also undergo serial blood
sampling for evaluation of viral RNA, hematology and biochemistry.

- Reside or have suitable living arrangements within a reasonable geographical area of
the study site and be able to participate in all follow-up visits

- Patients requiring corticosteroids must be on a stable dose of steroid for at least
two weeks prior to baseline MRI and when entered in the study. Maximum daily dose of
24 mg/day of dexamethasone/decadron or equivalent

Abbreviated Exclusion Criteria:

- Patients who are sexually active and not willing to use barrier methods of
contraception; women who are breastfeeding

- Patients with unstable or serious concurrent medical or psychiatric conditions that
would interfere with study treatment or follow-up

- Patients with more than one discrete enhancing lesion on MRI, or radiographic
evidence of satellite lesions or leptomeningeal disease not obviously contiguous by
FLAIR imaging

- Patients who may require further neurosurgery within 4 weeks after REOLYSIN®
treatment

- Patients with a prior history of encephalitis, multiple sclerosis or other
significant chronic CNS disease

- Patients who have evidence of a current CNS infection, meningeal gliomatosis or
gliomatosis cerebri

- Patients with tumor that to be treated would require needle or catheter passage
through a ventricle, the posterior fossa or basal ganglia; or patients with tumors
invading the ventricle

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